K242098
- 510(k) number
- K242098
- Device name
- Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
- Applicant
- Shenzhen Vivolight Medical Device & Technology Co., Ltd. CN
- Product code
- NQQ — System, Imaging, Optical Coherence Tomography (Oct)
- Decision date
- 2025-04-11
- Date received
- 2024-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242098.pdf
Official FDA record: K242098
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.